Gynecological tumor drug sustained-release stent
By designing a fixation component adapted to the pelvic cavity and a drug-release stent with adjustable drug release, the accuracy and stability issues of existing stents in the treatment of gynecological tumors have been resolved, improving treatment efficacy and patient comfort, and simplifying the stent removal process.
Patent Information
- Application Number
- CN202423087165.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-13
- Publication Date
- 2026-02-17
- Estimated Expiration
- 2034-12-13
AI Technical Summary
Existing drug-release stents cannot accurately target tumor tissue in the treatment of gynecological tumors. They are prone to displacement, uneven drug release, and are difficult to remove, affecting treatment efficacy and patient comfort.
A gynecological tumor drug-releasing stent was designed, which adopts an internal hollow tubular stent body, equipped with a fixation component and an auxiliary removal component. The fixation component is adapted to the female pelvic cavity, the thickness of the drug-releasing layer gradually increases, the drug release rate is adjustable, and the auxiliary removal component facilitates stent removal.
It increases the concentration of the drug at the tumor site and the therapeutic effect, reduces irritation to the vaginal mucosa, enhances the stability of treatment and patient comfort, and simplifies the stent removal process.
Smart Images
Figure CN223914272U_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical device technology, and in particular to a drug-releasing stent for gynecological tumors. Background Technology
[0002] In the treatment of gynecological tumors, traditional treatment methods such as surgery, radiotherapy, and chemotherapy, while effective for some patients, also have certain limitations. For example, systemic chemotherapy may cause a series of side effects, affecting the patient's quality of life. In recent years, with the development of biomaterials science, local drug delivery systems have gradually become a research hotspot. Among them, drug-release stents have received widespread attention because they can achieve continuous drug release, reduce the frequency of administration, and reduce toxic side effects.
[0003] Regarding the currently used drug-releasing stents, the inventors discovered the following drawbacks: 1. Some existing ordinary stents cannot guarantee that the drug will accurately act on the tumor tissue in the complex pelvic environment, and are prone to displacement due to the body's movements, affecting the treatment effect; 2. After most ordinary stents are installed, the drug release rate is basically the same in all positions, which leads to increased irritation of the vaginal mucosa; 3. The stent is not easy to remove, which can easily cause additional pain to the patient. Utility Model Content
[0004] This invention addresses the aforementioned problems in the existing technology by providing a gynecological tumor drug-releasing stent.
[0005] The objective of this utility model is mainly achieved through the following solution:
[0006] A gynecological tumor drug-releasing stent includes a stent body, a drug-releasing layer, a fixation component, and an auxiliary removal component. The stent body has an internally hollow tubular structure, with its upper and lower ends connected to the fixation component and the auxiliary removal component, respectively. The drug-releasing layer covers the outer surface of the stent body. The upper surface of the fixation component has an arc-shaped groove adapted to the shape of the top of the uterine cavity, and the surface of the arc-shaped groove is covered with bio-adhesive. The drug-releasing layer includes a polymer carrier and a therapeutic drug located on the polymer carrier. The auxiliary removal component includes a tail wire connected to the bottom of the stent body.
[0007] Preferably, the fixing component is made of silicone material, and its two ends are configured as hemispherical structures.
[0008] Preferably, the thickness of the drug sustained-release layer gradually increases from bottom to top.
[0009] Preferably, the auxiliary removal component further includes a hollow protective cylinder with an opening at the top and fixedly connected to the bottom of the support body, and the upper end of the tail screw is located inside the protective cylinder.
[0010] Preferably, the lower end of the tail wire is wrapped with a layer of medical silicone tubing after passing through the protective cylinder.
[0011] Preferably, the medical silicone tube is made of flesh-colored silicone.
[0012] Preferably, the outer surface of the medical silicone tube is provided with multiple protrusions.
[0013] In summary, compared with the prior art, the present invention has the following beneficial technical effects:
[0014] (1) The fixation component provided by this utility model is compatible with the structure of the female pelvis and vagina, and can accurately deliver the drug to the vicinity of the tumor site, increase the drug concentration in the tumor site, and enhance the killing power of tumor cells. Compared with traditional oral and intravenous injection methods, the treatment effect is more significant. Moreover, the fixation component is fixed to the uterine cavity with biological glue, which can ensure that the position of the stent in the body is relatively fixed and it is not easy to move even when the body is active. This helps the drug to act on the tumor site continuously and accurately, and improves the stability and reliability of the treatment.
[0015] (2) The thickness of the drug sustained-release layer provided by this utility model gradually increases from bottom to top, and the drug is mainly concentrated in the tumor site for release, which improves the therapeutic effect. The drug release rate near the bottom is relatively slow, which can reduce the stimulation of the vaginal mucosa and improve the patient's tolerance and comfort.
[0016] (3) With the auxiliary removal component set in this utility model, it is more convenient for medical staff to operate when the stent needs to be removed, and can avoid causing additional pain to the patient due to the difficulty of operation. Attached Figure Description
[0017] Figure 1 This is a schematic diagram of the structure of this utility model;
[0018] Figure 2 This is a schematic diagram of the internal structure of the bracket body and fixing components in this utility model;
[0019] Figure 3 yes Figure 2 Enlarged view of point A in the middle.
[0020] Reference numerals: 1-Staff body, 2-Drug sustained-release layer, 3-Fixing component, 4-Arc-shaped groove, 5-Bio-adhesive, 6-Tail wire, 7-Protective tube, 8-Medical silicone tube, 9-Protrusion. Detailed Implementation
[0021] The technical solution of this utility model will be further described in detail below through specific embodiments and in conjunction with the accompanying drawings. It should be understood that the implementation of this utility model is not limited to the following embodiments, and any modifications and / or alterations made to this utility model will fall within the protection scope of this utility model.
[0022] Example 1:
[0023] like Figure 1 , 2 As shown, this utility model discloses a technical solution: a gynecological tumor drug-releasing stent, which consists of a stent body 1, a drug-releasing layer 2, a fixing component 3, and an auxiliary removal component.
[0024] The aforementioned stent body 1 adopts an internally hollow tubular structure, and its upper and lower ends are fixedly bonded to the fixing component 3 and the auxiliary removal component, respectively. The drug sustained-release layer 2 covers the outer surface of the stent body 1. The stent body 1 is made of a biocompatible medical polymer material, such as polylactic acid-glycolic acid copolymer (PLGA).
[0025] The upper surface of the aforementioned fixing component 3 is provided with an arc-shaped groove 4 that matches the shape of the top of the uterine cavity. The surface of the arc-shaped groove 4 is provided with bio-adhesive 5. The fixing component 3 is made of silicone material. The bio-adhesive 5 can ensure that the position of the support is relatively fixed in the body and is not easy to shift even when the body is moving. At the same time, the flexibility of the silicone material can reduce damage to vaginal tissue.
[0026] The aforementioned drug sustained-release layer 2 consists of a polymer carrier and a therapeutic drug located on the polymer carrier. The drug can be selected according to the type of gynecological tumor. For example, cisplatin or other chemotherapy drugs can be used for cervical cancer, and paclitaxel or other drugs can be used for ovarian cancer. The polymer carrier is chitosan, which has good biocompatibility and degradability. The drug sustained-release layer 2 is prepared by microencapsulation technology, in which the drug is encapsulated in polymer microcapsules. The size and wall thickness of the microcapsules can control the release rate of the drug.
[0027] The aforementioned auxiliary removal components include a tail wire 6 connected to the bottom of the support body 1 and an internally hollow protective tube 7. The upper part of the tail wire 6 can be embedded or glued to the support body 1, and the upper end of the protective tube 7 is glued to the support body 1. The tail wire 6 is made of medical-grade high-strength nylon or polyester fiber material. These materials have good flexibility, strength and biocompatibility, which can ensure that they will not cause damage to human tissue during use.
[0028] Example 2:
[0029] like Figure 1 , 2As shown, this utility model discloses another technical solution, a gynecological tumor drug sustained-release stent, which differs from embodiment 1 in that the two ends of the above-mentioned fixing component 3 are set as hemispherical structures, which are adapted to the female pelvic cavity and vaginal structure, and avoid irritation to the female vaginal mucosa.
[0030] Example 3:
[0031] like Figure 1 , 2 As shown, this utility model discloses another technical solution, a gynecological tumor drug sustained-release stent, which differs from Example 1 in that the thickness of the drug sustained-release layer 2 gradually increases from bottom to top. The drug sustained-release layer 2 is thinner near the lower end, and the drug release rate is relatively slow to reduce irritation to the vaginal mucosa. The drug sustained-release layer 2 is thicker near the upper end, and the drug release rate is relatively fast because this part is closer to the tumor site and requires a higher drug concentration.
[0032] This embodiment provides a process for preparing the drug sustained-release layer 2:
[0033] 1. Material preparation
[0034] Drug selection: The drug is determined according to the type of gynecological tumor. For example, cisplatin can be used for cervical cancer and paclitaxel can be used for ovarian cancer. The drug must be of high purity and be pulverized to achieve a particle size of micron, such as 1-10 microns, to facilitate the subsequent encapsulation process and better control the release rate.
[0035] Polymer carrier: Select biocompatible and biodegradable materials such as chitosan and polylactic acid-glycolic acid copolymer (PLGA); taking chitosan as an example, it needs to be dissolved in a suitable acidic solution (such as acetic acid solution) to prepare a chitosan solution of a certain concentration, which can be between 1% and 5%.
[0036] 2. Microencapsulation preparation
[0037] 1) Emulsification-solvent evaporation method (using PLGA as a carrier):
[0038] The drug is dissolved or dispersed in an organic solution of PLGA. The organic solvent can be dichloromethane or ethyl acetate, and the ratio of drug to PLGA is determined according to the required drug loading, for example, the drug can account for 10%-50% of the total weight. This organic phase is then added to an aqueous phase containing an emulsifier (such as polyvinyl alcohol) to form a water-in-oil (O / W) emulsion. The concentration of the emulsifier is between 0.5% and 2%. The emulsion is uniformly dispersed by high-speed stirring (1000-5000 rpm) or ultrasonic emulsification (200-800 watts). Under stirring conditions, the organic solvent is evaporated to form drug-PLGA microcapsules. The evaporation of the organic solvent can be accelerated by methods such as vacuum evaporation, with the temperature controlled between room temperature and 40°C to obtain microcapsules with uniform particle size.
[0039] 2) Ion gelation method (using chitosan as a carrier):
[0040] The drug is mixed thoroughly with a chitosan solution and then added dropwise to a solution containing sodium tripolyphosphate (TPP). The mass ratio of TPP to chitosan can be between 1:2 and 1:5. During the dropwise addition, the amino groups on the chitosan undergo an ionic cross-linking reaction with the TPP to form microcapsules. The particle size and morphology of the microcapsules are adjusted by controlling the dropwise addition rate (e.g., 1-5 mL / min) and the stirring speed (300-1000 rpm).
[0041] 3. Formation of the drug sustained-release layer
[0042] The prepared microcapsules are coated onto the surface of the scaffold body 1 by spraying or dipping. For spraying, a precision spraying device can be used to evenly spray the microcapsule suspension onto the scaffold body 1. The amount of each spray can be controlled from a few microliters to tens of microliters, and multiple sprays are made until the required thickness is achieved. For dipping, the scaffold body 1 is immersed in the microcapsule suspension for a certain period of time (e.g., 5-30 minutes), and then slowly removed and air-dried or dried at low temperature to allow the microcapsules to adhere to the scaffold body 1.
[0043] Near the lower part, the drug release layer can be kept thin by reducing the number of times the microcapsules are sprayed or impregnated; near the upper part, the number of operations can be increased to make the drug release layer thicker, thereby achieving different drug release rates in different parts. At the same time, the structural stability and drug release characteristics of the drug release layer can be further controlled by adjusting the concentration and amount of the binder between the microcapsules (such as a small amount of medical-grade gelatin solution).
[0044] Example 4:
[0045] like Figure 2 , 3As shown, this utility model discloses another technical solution, a gynecological tumor drug sustained-release stent, which differs from Embodiment 1 in that the upper part of the protective tube 7 of the above-mentioned auxiliary removal component is open and is bonded to the bottom of the stent body 1, and the upper end of the tail wire 6 is located inside the protective tube 7.
[0046] Specifically, the lower end of the tail wire 6 passes through the protective tube 7 and is wrapped with a layer of medical silicone tube 8. The medical silicone tube 8 is made of flesh-colored silicone, and the outer surface of the medical silicone tube 8 is provided with multiple protrusions 9. The function of the medical silicone tube 8 is to further protect the vaginal tissue. The color of the medical silicone tube 8 can be selected to be flesh-colored similar to the vaginal mucosa to reduce visual abruptness. At the same time, some small protrusions 9 are provided on the outer surface of the medical silicone tube 8. These protrusions can better fix the position of the tail wire 6 to a certain extent, but the protrusions 9 must be rounded enough to avoid damaging the tissue.
[0047] When the stent needs to be removed, medical staff can slowly and steadily pull it out through the medical silicone tube 8 outside the vagina. During the pulling process, care should be taken to ensure that the direction of the tail wire 6 is consistent with the axis of the vagina to avoid abrasion of the vaginal wall due to angular deviation. In addition, the bio-adhesive 5 used to fix the component has special properties. It can maintain good adhesion to fix the stent while it is attached to the vaginal mucosa, but its adhesion will decrease due to changes in specific conditions when it needs to be removed. This bio-adhesive is degradable or soluble. For example, it can be designed to degrade on its own after a certain period of time, or to lose its adhesion when it comes into contact with specific solvents or environments. When the stent needs to be removed, the adhesion of the bio-adhesive can be reduced by injecting a mild solution that interacts with the bio-adhesive (such as a buffer solution with a specific pH value) into the vagina, thereby easily separating the fixation component from the vaginal mucosa and avoiding the use of forceful pulling.
[0048] This invention provides a gynecological tumor drug-releasing stent with a fixation component adapted to the female pelvic and vaginal structures. This allows for accurate drug delivery to the vicinity of the tumor site, increasing local drug concentration and enhancing the killing effect on tumor cells. Compared to traditional oral or intravenous administration methods, the therapeutic effect is more significant. The fixation component is secured to the uterine cavity with bio-adhesive, ensuring the stent's relatively stable position within the body and preventing displacement even during activity. This helps the drug continuously and accurately act on the tumor site, improving the stability and reliability of the treatment. The thickness of the drug-releasing layer gradually increases from bottom to top, concentrating drug release at the tumor site for enhanced therapeutic efficacy. The slower drug release near the lower end reduces irritation to the vaginal mucosa, improving patient tolerance and comfort. The included auxiliary removal component makes stent removal easier for medical staff, avoiding additional pain for the patient due to operational difficulties.
[0049] The above are all preferred embodiments of this application, and are not intended to limit the scope of protection of this application. Therefore, all equivalent changes made in accordance with the structure, shape and principle of this application should be covered within the scope of protection of this application.
Claims
1. A drug-releasing stent for gynecological tumors, characterized in that: The stent body (1) includes a drug-releasing layer (2), a fixation component (3), and an auxiliary removal component. The stent body (1) has a hollow tubular structure, and its upper and lower ends are connected to the fixation component (3) and the auxiliary removal component, respectively. The drug-releasing layer (2) covers the outer surface of the stent body (1). The upper surface of the fixation component (3) is provided with an arc-shaped groove (4) that matches the shape of the top of the uterine cavity. The surface of the arc-shaped groove (4) is provided with bio-adhesive (5). The drug-releasing layer (2) includes a polymer carrier and a therapeutic drug located on the polymer carrier. The auxiliary removal component includes a tail wire (6) connected to the bottom of the stent body (1).
2. The gynecological tumor drug-releasing stent according to claim 1, characterized in that: The fixing component (3) is made of silicone material and its two ends are set as hemispherical structures.
3. The gynecological tumor drug-releasing stent according to claim 1, characterized in that: The thickness of the drug sustained-release layer (2) gradually increases from bottom to top.
4. The gynecological tumor drug-releasing stent according to claim 1, characterized in that: The auxiliary removal component also includes a hollow protective cylinder (7), the upper part of which is open and fixedly connected to the bottom of the support body (1), and the upper end of the tail wire (6) is located inside the protective cylinder (7).
5. The gynecological tumor drug-releasing stent according to claim 4, characterized in that: The lower end of the tail wire (6) passes through the protective tube (7) and is wrapped with a layer of medical silicone tube (8).
6. The gynecological tumor drug-releasing stent according to claim 5, characterized in that: The medical silicone tube (8) is made of flesh-colored silicone.
7. The gynecological tumor drug-releasing stent according to claim 6, characterized in that: The outer surface of the medical silicone tube (8) is provided with multiple protrusions (9).